The examinations of blood samples or other samples of body fluids, such as interstitial fluid, for example, enable, in clinical diagnostics, early and reliable identification of pathological states and targeted and astute monitoring of body states. Medical diagnostics generally presupposes that a sample of blood or interstitial fluid is obtained from the patient to be examined. In order to obtain the sample, the skin of the person to be examined can be perforated, for example at the finger pad or the ear lobe, with the aid of a sterile, pointed or sharp lancet in order thus to obtain for example a few microliters of blood or less for analysis. In particular, this method is suitable for an analysis of the sample which is carried out directly after the sample has been obtained. Primarily in the field of so-called “home monitoring”, that is to say where medical laypersons themselves carry out simple analyses of blood of interstitial fluid, in particular for diabetics obtaining blood samples on a regular basis, several times a day, to monitor the blood glucose concentration, lancets and associated devices, so-called puncturing aids, are offered. These are described for example in WO-A 98/48695, U.S. Pat. No. 4,442,836, U.S. Pat. No. 5,554,166 or WO 2006/013045 A1, each of which are hereby incorporated herein by reference in their respective entireties.
Self-monitoring of blood sugar levels is a method of diabetes control that is nowadays applied worldwide. Blood sugar devices in the prior art generally have an analysis device into which a test element (for example a test strip or an analysis tape) is introduced. The sample to be analyzed is applied to a test field of the test element and reacts in the test field with one or more reagents, if appropriate, before it is analyzed. Optical, in particular photometric, and electrochemical evaluation of test elements are the most common methods for rapidly determining the concentration of analytes in samples. Analysis systems comprising test elements for sample analysis are generally used in the field of analysis, environmental analysis, and in the field of medical diagnostics.
The prior art discloses various forms of test elements and test devices for the evaluation thereof. By way of example, strip-type test elements can be used, such as are described for example in the documents CA 2311496 A1, U.S. Pat. No. 5,846,838 A, U.S. Pat. No. 6,036,919 A or WO 97/02487, each of which are hereby incorporated herein by reference in their respective entireties. Further multilayered test elements known in the prior art are analysis tapes comprising a multiplicity of test fields which are provided in a cassette in a manner wound up for use in an analysis device. Such cassettes and analysis tapes are described for example in the documents DE 10 332 488 A1, DE 10 343 896 A1, EP 1 424 040 A1, WO 2004/056269 A1 or US 2006/0002816 A1, each of which are hereby incorporated herein by reference in their respective entireties.
Besides analysis tapes comprising test fields, analysis tapes in which lancets are arranged on a carrier tape have also become known in the meantime, wherein the individual lancets, by means of tape transport, can be progressively used and also disposed of again. One example of a system of this type is shown in WO-A 2005/107596, which is hereby incorporated herein by reference in its entirety.
Hereinafter, therefore, an analysis tape is understood to mean generally a tape with any desired type of diagnostic aids, wherein the diagnostic aids can comprise any desired type of diagnostic aids, for example diagnostic test fields with a detection chemical and/or lancets. A tape can be understood to mean, besides a continuous, strip-type element, in principle, generally any desired transport element which is configured such that it is at least in part pliable, deformable or flexible and which can be configured for example also in the form of a chain, a cord, a link chain or a similar continuous carrier.
Various methods are known from the prior art for producing the analysis tapes. These methods have to satisfy numerous stringent requirements since, in the field of medical diagnostics, stringent requirements are made for example of freedom from contamination for the analysis tapes, and also stringent requirements are made of the quality and the reproducibility of the diagnostic aids applied on the analysis tapes. At the same time, however, the analysis tapes have to be produced cost-effectively since medical diagnostics is under constantly increasing cost pressure.
Exemplary disclosures relating to methods and devices for producing analysis tapes and relating to process and devices ancillary thereto include EP 1 593 434 A2, PCT/EP 2008/064614, US 2003/0111184 A1, EP 1 837 170 A1, U.S. Pat. No. 6,633,740 B2, U.S. Pat. No. 5,024,717, U.S. Pat. No. 2,303,346, EP 0 833 778 B1, DE 41 39 924, each of which are hereby incorporated herein by reference in their respective entireties.
However, such various methods and devices do not completely solve the problem of the requirement for cost-effective and at the same time high-precision production of high-quality analysis tapes with a high throughput. Known methods are restricted in terms of their throughput and can typically be used only for tape speeds of less than one meter per minute with an acceptable tolerance during processing. In addition, many of the known methods have high analysis material rejects, which is unacceptable in view of the rising cost pressure.
Therefore, it is an object of the present invention to provide a method and a device for producing a tape product comprising diagnostic aids which avoid the disadvantages of known methods and which can produce high-precision analysis tapes cost-effectively and with a very high throughput.